Premier Adenoclone
Premier Adenoclone is an Enzyme immunoassay (EIA) for the qualitative detection of human adenoviruses directly from stool specimens and confirms the presence of adenovirus in cell culture…
Premier Adenoclone is an Enzyme immunoassay (EIA) for the qualitative detection of human adenoviruses directly from stool specimens and confirms the presence of adenovirus in cell culture isolates from respiratory, ophthalmic or enteric specimens.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 21 |
Record
| Listed by | Meridian Bioscience, Inc., United States |
|---|---|
| FDA product code | GOD |
| Device type | Antigens, Cf (Including Cf Control), Adenovirus 1-33 |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3020 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K873082 |
| Record published | 2020-10-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 696007 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Adenovirus IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Chorus Adenovirus IgG | Diesse Diagnostica Senese SPA | 1 |
| Rapid Response | Btnx Inc. | 1 |
| InflammaDry | Quidel Corp. | 1 |
| Adenovirus IgG Elisa | DRG International, Inc. | 1 |
| Quadrox-i | Maquet Cardiopulmonary GmbH | 1 |
| Premier Adenoclone Type 40/41 | Meridian Bioscience, Inc. | 1 |
| AdenoPlus | Quidel Corp. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.